Výsledky vyhledávání - "Oleg Malievskiy"

Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results

Publikováno v: The Journal of clinical endocrinology and metabolism. 107(7)

Purpose The objectives of the ongoing, Phase 3, open-label extension trial enliGHten are to assess the long-term safety and efficacy of weekly administered long-acting growth hormone lonapegsomatropin in children with growth hormone deficiency. Metho

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::265b429f9e88e65a20a36daf9f9774cd
https://pubmed.ncbi.nlm.nih.gov/35428884

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Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study

Autor: Cheri L Deal, Joel Steelman, Elpis Vlachopapadopoulou, Renata Stawerska, Lawrence A Silverman, Moshe Phillip, Ho-Seong Kim, CheolWoo Ko, Oleg Malievskiy, Jose F Cara, Carl L Roland, Carrie Turich Taylor, Srinivas Rao Valluri, Michael P Wajnrajch, Aleksandra Pastrak, Bradley S Miller

Publikováno v: The Journal of clinical endocrinology and metabolism. 107(7)

Context Somatrogon is a long-acting recombinant human growth hormone (rhGH) in development for once-weekly treatment of children with growth hormone deficiency (GHD). Objective We aimed to compare the efficacy and safety of once-weekly somatrogon wit

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1f66df9daab29abb1a313f0506af8d89
https://pubmed.ncbi.nlm.nih.gov/35405011

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RF26 | PMON332 Safety and Efficacy of Treatment with Lonapegsomatropin in Children with Growth Hormone Deficiency at Week 130 in the enliGHten Trial

Autor: Paul Saenger, Ulhas Nadgir, Paul Hofman, Paul Thornton, Elena D Chertok, Elena M Aghajanova, Maria Korpal-Szczyrska, Elpis Vlachopapadopoulou, Oleg Malievskiy, Tetyana Chaychenko, Marco Cappa, Wenjie Song, Meng Mao, Steven D Chessler, Allison S Komirenko, Michael Beckert, Aimee D Shu, Aristides K Maniatis

Publikováno v: Journal of the Endocrine Society. 6:A645-A645

Background Once-weekly lonapegsomatropin (TransCon hGH) is a long-acting prodrug of somatropin, recently approved for the treatment of pediatric growth hormone deficiency (GHD) by the US FDA. In the pivotal 52-week phase 3 heiGHt trial and the 26-wee

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f2331a24785a2da58c53d2ed97ab1f12
https://doi.org/10.1210/jendso/bvac150.1334

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SAT-LB15 24-Month Efficacy and Safety of Once Weekly and Every Other Week Administration of GX-H9, Hybrid FC-Fused Long-Acting Human Growth Hormone: A Phase 2 Study in Children With Growth Hormone Deficiency

Publikováno v: Journal of the Endocrine Society

Objectives GX-H9 is a long-acting form of recombinant human GH under clinical development for both adults and children with GHD. In this report, 24-month efficacy and safety of once weekly and every other week (EOW) administration of GX-H9 were evalu

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::39c85b2dde943e28718cd39d8b55e896
http://europepmc.org/articles/PMC7208270

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Results From an Open-Label Extension of the Phase 2 Dose Finding Study of Once Weekly Somatrogon vs Daily Genotropin in Pediatric Patients With Growth Hormone Deficiency (GHD)

Autor: Ron G. Rosenfeld, Srinivas Rao Valluri, Nataliya Zelinska, Zvi Zadik, Nelly Mauras, Violeta Iotova, Aleksandra Pastrak, Oleg Malievskiy, Yulia Skorodok

Publikováno v: Journal of the Endocrine Society. 5:A684-A685

Background: Somatrogon, a long-acting recombinant human growth hormone, is being developed as a once weekly treatment for pediatric patients (pts) with GHD. A phase 2, 12 month study (NCT01592500) in pts with GHD showed that weekly somatrogon at 0.66

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::20f9eb8c56ee57ee1ef4069454418abb
https://doi.org/10.1210/jendso/bvab048.1395

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Switch Data From the Open-Label Extension of the Pivotal Phase 3 Study of Once Weekly Somatrogon Compared to Daily Somatropin in Pediatric Patients With Growth Hormone Deficiency (pGHD)

Autor: Ho-Seong Kim, Oleg Malievskiy, Cheol Woo Ko, Bradley S. Miller, Elpis Vlachopapadopoulou, Cheri Deal, Joel Steelman, Carrie T. Taylor, John Choe, Michael Wajnrajch, Moshe Phillip, Carl L. Roland, Aleksandra Pastrak, Renata Stawerska, Lawrence A. Silverman, Srinivas Rao Valluri

Publikováno v: Journal of the Endocrine Society. 5:A686-A687

Objectives: Somatrogon (hGH-CTP) is a long acting recombinant human growth hormone, consisting of the amino acid sequence of hGH and three copies of the carboxy-terminal peptide (CTP) of human chorionic gonadotropin (hCG) being developed as a once we

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f04d87348231a6b5998f3257b8d3d5eb
https://doi.org/10.1210/jendso/bvab048.1399

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A Randomized Phase 2 Study of Long-Acting TransCon GH vs Daily GH in Childhood GH Deficiency

Autor: Magdy O Abdou, Valentina Alexandrovna Peterkova, Yulia Skorodok, Ganna Senatorova, Elpis Vlachopapadopoulou, Pierre Chatelain, Klaudziya Radziuk, Jonathan A Leff, Michael Beckert, Oleg Malievskiy

Publikováno v: The Journal of Clinical Endocrinology & Metabolism. 102:1673-1682

Context: TransCon Growth Hormone (GH) (Ascendis Pharma) is a long-acting recombinant sustained-release human GH prodrug in development for children with GH deficiency (GHD). Objective: To compare the pharmacokinetics, pharmacodynamics, safety, and ef

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::804090af5fd43603cf73801a7a631eb0
https://doi.org/10.1210/jc.2016-3776

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